U.S. patent application number 13/549828 was filed with the patent office on 2013-07-18 for devices and methods for transnasal irrigation or suctioning of the sinuses.
The applicant listed for this patent is Eric A. Goldfarb, Arthur M. Lin, Richard R. Newhauser, JR., John W. White. Invention is credited to Eric A. Goldfarb, Arthur M. Lin, Richard R. Newhauser, JR., John W. White.
Application Number | 20130184574 13/549828 |
Document ID | / |
Family ID | 47601718 |
Filed Date | 2013-07-18 |
United States Patent
Application |
20130184574 |
Kind Code |
A1 |
Newhauser, JR.; Richard R. ;
et al. |
July 18, 2013 |
DEVICES AND METHODS FOR TRANSNASAL IRRIGATION OR SUCTIONING OF THE
SINUSES
Abstract
An irrigation catheter for the treatment of the sinus anatomy is
described. The catheter comprises a proximal portion, a rigid
middle portion, and a flexible distal portion. The flexible distal
portion comprises an irrigation tip and the proximal portion has a
stiffness that is intermediate the stiffness of the rigid middle
portion and the flexible distal portion. The irrigation tip has a
tip opening and one or more radially facing openings. A method for
irrigating or suctioning the sinus anatomy includes inserting an
irrigation catheter into a patient's anatomy and irrigating or
suctioning a target space.
Inventors: |
Newhauser, JR.; Richard R.;
(Redwood City, CA) ; Goldfarb; Eric A.; (Belmont,
CA) ; White; John W.; (San Francisco, CA) ;
Lin; Arthur M.; (Fremont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Newhauser, JR.; Richard R.
Goldfarb; Eric A.
White; John W.
Lin; Arthur M. |
Redwood City
Belmont
San Francisco
Fremont |
CA
CA
CA
CA |
US
US
US
US |
|
|
Family ID: |
47601718 |
Appl. No.: |
13/549828 |
Filed: |
July 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61511320 |
Jul 25, 2011 |
|
|
|
Current U.S.
Class: |
600/431 ;
604/275; 604/514 |
Current CPC
Class: |
A61B 17/24 20130101;
A61M 3/0279 20130101; A61M 25/0054 20130101; A61M 3/0283
20130101 |
Class at
Publication: |
600/431 ;
604/275; 604/514 |
International
Class: |
A61M 3/02 20060101
A61M003/02 |
Claims
1. An irrigation catheter for the treatment of a sinus, the
catheter having an irrigation lumen, said catheter comprising: a
proximal portion: a rigid middle portion ; and a flexible distal
portion; wherein the flexible distal portion comprises an
irrigation tip and wherein the proximal portion has a stiffness
that is intermediate the stiffness of said rigid middle portion and
said flexible distal portion.
2. The catheter of claim 1 wherein the irrigation tip comprises a
tip opening and one or more radially facing openings.
3. The catheter of claim 2 wherein the one or more radially facing
openings comprise 3 openings.
4. The catheter of claim 3 wherein the radially facing openings
have a diameter of between 0.020 inches and 0.050 inches.
5. The catheter of claim 4 wherein the radially facing openings
have a diameter of 0.026 inches.
6. The catheter of claim 1 wherein the rigid middle portion
comprises a stiffening member that surrounds the irrigation
lumen.
7. The catheter of claim 6 wherein the stiffening member is a
hypotube.
8. The catheter of claim 1 wherein the proximal portion comprises a
nylon sleeve that surrounds the irrigation lumen.
9. The catheter of claim 1 wherein the medical device further
comprises one or more direct visualization markers.
10. The catheter of claim 1 wherein the medical device further
comprises one or more radiographic markers.
11. The catheter of claim 1 wherein the medical device further
comprises a dual-use connector selected from the group consisting
of a y-connector and a valve.
12. The catheter of claim 1 wherein the rigid middle portion
further comprises an actuator.
13. A system for treatment of a target space in the nasal anatomy,
said system comprising: a handle; a guide catheter for attachment
to the handle, said guide catheter having an inner diameter; and an
irrigation catheter having an outer diameter, the outer diameter of
the irrigation catheter being smaller than the inner diameter of
the guide catheter, wherein said irrigation catheter having an
irrigation lumen, said irrigation catheter comprising a proximal
portion, a rigid middle portion; and a flexible distal portion
having an irrigation tip, said proximal portion having a stiffness
that is intermediate the stiffness of said rigid middle portion and
said flexible distal portion.
14. The system of claim 13 wherein the proximal portion comprises a
luer connector.
15. The system of claim 13 wherein the luer connector comprises a
slanted positioner.
16. The system of claim 13 further including a guidewire.
17. A method for treating a target space in the nasal anatomy, said
method comprising: positioning an irrigation catheter having an
irrigation lumen, said catheter comprising a proximal portion, a
rigid middle portion and a flexible distal portion in the nasal
anatomy, wherein the flexible distal portion comprises an
irrigation tip and wherein the proximal portion has a stiffness
that is intermediate the stiffness of said rigid middle portion and
said flexible distal portion; connecting a fluid source to the
irrigation catheter; delivering fluid to the target space from the
fluid source though the irrigation lumen.
18. The method of claim 17 wherein the delivering the fluid occurs
at a flow rate of between 50 ml/min and 200 ml/min
19. The method of claim 18 wherein the flow rate is between 75
ml/min and 125 ml/min.
20. The method of claim 17 wherein the target space is selected
from the group consisting of the frontal sinus, the maxillary
sinus, the ethmoid sinus, and the sphenoid sinus opening.
21. The method of claim 17 wherein the fluid is selected from the
group consisting of water, saline, contrast agents, antimicrobial
agents anti-inflammatory agents, decongestants , mucous thinning
agents, anesthetic agents, analgesic agents, anti-allergenic
agents, allergens, anti-proliferative agents, hemostatic agents,
cytotoxic agents, and biological agents or combinations of any of
the above.
22. A method for treating a target space in the nasal anatomy, said
method comprising: positioning an irrigation catheter having an
irrigation lumen, said irrigation catheter comprising a proximal
portion, a rigid middle portion and a flexible distal portion in
the nasal anatomy, wherein the flexible distal portion comprises an
irrigation tip and wherein the proximal portion has a stiffness
that is intermediate the stiffness of said rigid middle portion and
said flexible distal portion; connecting a vacuum source to the
irrigation catheter; suctioning the target space though the
irrigation lumen.
23. The method of claim 22 wherein the target space is selected
from the group consisting of the frontal sinus, the maxillary
sinus, the ethmoid sinus, and the sphenoid sinus opening.
24. An irrigation catheter having an irrigation lumen, said
catheter comprising: a proximal portion; a rigid middle portion;
and a flexible distal portion; wherein the flexible distal portion
comprises an irrigation tip and wherein the middle portion
comprises an actuator.
25. The catheter of claim 24 wherein the proximal portion is a
rigid proximal portion and further comprises an irrigation
connector.
26. The irrigation catheter of claim 24 wherein the actuator
comprises a distal actuator flange and a proximal actuator
flange.
27. The irrigation catheter of claim 24 wherein the irrigation tip
comprises a tip opening and one or more radially facing
openings.
28. The irrigation catheter of claim 24 wherein the rigid middle
portion comprises a stiffening member that surrounds the irrigation
lumen.
29. The irrigation catheter of claim 25 wherein the rigid proximal
portion comprises a stiffening member that surrounds the irrigation
lumen.
30. A system for treatment of a target space in the nasal anatomy,
said system comprising: a handle; a guide catheter for attachment
to the handle, said guide catheter having an inner diameter and an
irrigation catheter having an outer diameter, the outer diameter of
the irrigation catheter being smaller than the inner diameter of
the guide catheter; wherein said irrigation catheter has an
irrigation lumen and wherein said irrigation catheter comprises a
proximal portion, a rigid middle portion, and a flexible distal
portion having an irrigation tip, said middle portion comprising an
actuator.
31. The system of claim 30 wherein the irrigation catheter proximal
portion is a rigid proximal portion and further comprises an
irrigation connector.
32. The system of claim 30 wherein the irrigation catheter actuator
comprises a distal actuator flange and a proximal actuator
flange.
33. The system of claim 30 wherein the irrigation tip or the
irrigation catheter comprises a tip opening and one or more
radially facing openings.
34. The system of claim 30 wherein the irrigation catheter rigid
middle portion comprises a stiffening member that surrounds the
irrigation lumen.
35. The system of claim 31 wherein irrigation catheter rigid
proximal portion comprises a stiffening member that surrounds the
irrigation lumen.
36. A method for treating a target space in the nasal anatomy, said
method comprising: positioning an irrigation catheter having an
irrigation lumen, said catheter comprising a proximal portion, a
rigid middle portion and a flexible distal portion in the nasal
anatomy, wherein the flexible distal portion comprises an
irrigation tip and the rigid middle portion comprises an actuator;
connecting a fluid source to the irrigation catheter; delivering
fluid to the target space from the fluid source though the
irrigation lumen.
37. The method of claim 36 wherein the delivering the fluid occurs
at a flow rate of between 50 ml/min and 200 ml/min
38. The method of claim 36 wherein the target space is selected
from the group consisting of the frontal sinus, the maxillary
sinus, the ethmoid sinus, and the sphenoid sinus opening.
39. The method of claim 36 wherein the fluid is selected from the
group consisting of water, saline, contrast agents, antimicrobial
agents anti-inflammatory agents, decongestants , mucous thinning
agents, anesthetic agents, analgesic agents, anti-allergenic
agents, allergens, anti-proliferative agents, hemostatic agents,
cytotoxic agents, and biological agents or combinations of any of
the above.
40. A method for treating a target space in the nasal anatomy, said
method comprising: positioning an irrigation catheter having an
irrigation lumen, said irrigation catheter comprising a proximal
portion, a rigid middle portion and a flexible distal portion in
the nasal anatomy, wherein the flexible distal portion comprises an
irrigation tip and wherein the rigid middle portion comprises an
actuator; connecting a vacuum source to the irrigation catheter;
suctioning the target space though the irrigation lumen.
41. The method of claim 40 wherein the target space is selected
from the group consisting of the frontal sinus, the maxillary
sinus, the ethmoid sinus, and the sphenoid sinus opening.
Description
FIELD OF THE INVENTION
[0001] The present invention relates, in general, to medical
devices and, in particular, to medical devices and related methods
for the treatment of sinus conditions.
BACKGROUND OF THE INVENTION
[0002] The paranasal sinuses are hollow cavities in the skull
connected by small openings, known as ostia, to the nasal canal.
Each ostium between a paranasal sinus and the nasal cavity is
formed by a bone covered by a layer of mucosal tissue. Normally,
air passes into and out of the paranasal sinuses through the ostia.
Also, mucus is continually formed by the mucosal lining of the
sinuses and drains through the ostia and into the nasal canal.
[0003] Sinusitis is a general term that refers to inflammation in
one or more of the paranasal sinuses. Acute sinusitis can be
associated with upper respiratory infections or allergic
conditions, which may cause tissue swelling and temporarily impede
normal trans-ostial drainage and ventilation of the sinuses,
thereby resulting in some collection of mucus and possibly
infection within the sinus cavities. Chronic sinusitis is a long
term condition characterized by persistent narrowing or blockage of
one or more sinus ostia, resulting in chronic infection and
inflammation of the sinuses. Chronic sinusitis is often associated
with longstanding respiratory allergies, nasal polyps, hypertrophic
nasal turbinates and/or deviated internasal septum. While acute
sinusitis is typically caused by infection with a single pathogen
(e.g., one type of bacteria, one type of virus, one type of fungus,
etc.), chronic sinusitis is often associated with multiple pathogen
infections (e.g., more than one type of bacteria or more than one
genus of micro-organism).
[0004] Chronic sinusitis, if left untreated, can result in
irreparable damage to the tissues and/or bony structures of the
paranasal anatomy. The initial treatment of chronic sinusitis
usually involves the use of drugs such as decongestants, steroid
nasal sprays and antibiotics (if the infection is bacterial). In
cases where drug treatment alone fails to provide permanent relief,
surgical intervention may be indicated.
[0005] The most common surgical procedure for treating chronic
sinusitis is functional endoscopic sinus surgery (FESS). FESS is
commonly performed using an endoscope and various rigid instruments
inserted through the patient's nostril. The endoscope is used to
visualize the positioning and use of various rigid instruments used
for removing tissue from the nasal cavity and sinus ostia in an
attempt to improve sinus drainage.
[0006] A technique known as the Balloon Sinuplasty.TM. procedure
and a system for performing the procedure has been developed by
Acclarent Inc, of Menlo Park, Calif. for treatment of sinusitis. A
number of US patents and patent applications including U.S. Pat.
Nos. 7,645,272, 7,654,997, and 7,803,150 describe various
embodiments of the Balloon Sinuplasty.TM. procedure as well as
various devices useable in the performance of such procedure. In
the Balloon Sinuplasty.TM. procedure, a guide catheter is inserted
into the nose and positioned within or adjacent to the ostium of
the affected paranasal sinus. A guidewire is then advanced through
the guide catheter and into the affected paranasal sinus.
Thereafter, a dilation catheter having an expandable dilator (e.g.
an inflatable balloon) is advanced over the guidewire to a position
where the dilator is positioned within the ostium of the affected
paranasal sinus. The dilator is then expanded, causing dilation of
the ostium and remodelling of bone adjacent to the ostium, without
required incision of the mucosa or removal of any bone. The
catheters and guidewire are then removed and the dilated ostium
allows for improved drainage from and ventilation of the affected
paranasal sinus.
[0007] Before or after performing a FESS or Balloon Sinuplasty.TM.
procedure, it may be useful or necessary to suction or irrigate the
paranasal sinus. A device described in U.S. 2008/0183128 may be
used for irrigating a paranasal sinus. The irrigation catheter may
be advanced through a guide catheter and into an ostium or the
sinus for purposes of, for example irrigation, suctioning,
substance delivery and culture retrieval.
[0008] There is a continuing need for improved methods and devices
for treating the paranasal sinus. Although the irrigation catheter
described above is easy to use, it would be useful to provide an
improved catheter for irrigating or suctioning the sinuses before
or after the Balloon Sinuplasty.TM. procedure.
SUMMARY OF THE INVENTION
[0009] In a first aspect, the invention is an irrigation catheter
for the treatment of a sinus, the catheter having an irrigation
lumen, and further having a proximal portion, a rigid middle
portion and a flexible distal portion. The flexible distal portion
has an irrigation tip and the proximal portion has a stiffness that
is intermediate the stiffness of the rigid middle portion and the
flexible distal portion.
[0010] In one embodiment, the irrigation tip has a tip opening.
There may be one or more radially facing openings. In a particular
embodiment, there may be 3 radially facing openings. In a further
embodiment the radailly facing openings may have a diameter of
between 0.020 inches and 0.050 inches, or they may have a diameter
of 0.026 inches.
[0011] In another embodiment the rigid middle portion of the
irrigation catheter may contain a stiffening member that surrounds
the irrigation lumen. The stiffening member may be a hypotube. In
addition, the catheter proximal portion may contain a nylon sleeve
that surrounds the irrigation lumen.
[0012] In a further embodiment, the irrigation catheter may have
one or more direct visualization markers or one or more
radiographic markers. Further, a dual use connector may further be
included. The connector may be a y-connector or a valve. The rigid
middle portion may further include an actuator.
[0013] In a further aspect, the invention is a system for treatment
of a target space in the nasal anatomy having a handle, a guide
catheter for attachment to the handle, and an irrigation catheter
with an outer diameter that is smaller than the inner diameter of
the guide catheter. The irrigation catheter has an irrigation lumen
and further has a proximal portion, a rigid middle portion; and a
flexible distal portion with an irrigation tip, the proximal
portion having a stiffness that is intermediate the stiffness of
the rigid middle portion and the flexible distal portion
[0014] In a further embodiment, the system having a handle, a guide
catheter, and an irrigation catheter, may have a luer connector on
the irrigation catheter. In one embodiment, the luer connector may
have a slanted positioner. A guidewire may further be included.
[0015] In another aspect, the invention is a method for treating a
target space in the nasal anatomy. The method involves positioning
an irrigation catheter having an irrigation lumen and further
having a proximal portion, a rigid middle portion and a flexible
distal portion in the nasal anatomy. The flexible distal portion
has an irrigation tip and the proximal portion has a stiffness that
is intermediate the stiffness of the rigid middle portion and the
flexible distal portion. The method further involves connecting a
fluid source to the irrigation catheter and delivering fluid to the
target space from the fluid source though the irrigation
catheter.
[0016] In another embodiment the method includes the delivering the
fluid at a flow rate of between 50 ml/min and 200 ml/min or between
75 ml/min and 125 ml/min.
[0017] In a further embodiment of the method, the target space is
selected from the group consisting of the frontal sinus, the
maxillary sinus, the ethmoid sinus, and the sphenoid sinus
opening.
[0018] In yet another embodiment of the method, the fluid is
selected from the group consisting of water, saline, contrast
agents, antimicrobial agents anti-inflammatory agents,
decongestants , mucous thinning agents, anesthetic agents,
analgesic agents, anti-allergenic agents, allergens,
anti-proliferative agents, hemostatic agents, cytotoxic agents, and
biological agents or combinations of any of the above.
[0019] In a third aspect, the invention is a method for treating a
target space in the nasal anatomy. The method involves positioning
an irrigation catheter having an irrigation lumen and further
having a proximal portion, a rigid middle portion and a flexible
distal portion in the nasal anatomy. The flexible distal portion
has an irrigation tip and the proximal portion has a stiffness that
is intermediate the stiffness of the rigid middle portion and the
flexible distal portion. The method further involves connecting a
vacuum source to the irrigation catheter and suctioning the target
space though the irrigation lumen.
[0020] In another embodiment of the method, the target space is
selected from the group consisting of the frontal sinus, the
maxillary sinus, the ethmoid sinus, and the sphenoid sinus
opening.
[0021] In another aspect, the invention is an irrigation catheter
for the treatment of a sinus, the catheter having an irrigation
lumen, and further having a proximal portion, a rigid middle
portion and a flexible distal portion. The flexible distal portion
has an irrigation tip and the middle portion has an actuator.
[0022] In one embodiment, the proximal portion has is a rigid
proximal portion and further includes an irrigation connector. In a
further embodiment the actuator has a distal actuator flange and a
proximal actuator flange. In another embodiment, the irrigation tip
has a tip opening and one or more radially facing openings.
[0023] In another embodiment the rigid middle portion of the
irrigation catheter may contain a stiffening member that surrounds
the irrigation lumen. In addition, the catheter proximal portion
may contain a stiffening member that surrounds the irrigation
lumen.
[0024] In a further aspect, the invention is a system for treatment
of a target space in the nasal anatomy having a handle, a guide
catheter for attachment to the handle, and an irrigation catheter
with an outer diameter that is smaller than the inner diameter of
the guide catheter. The irrigation catheter has an irrigation lumen
and further has a proximal portion, a rigid middle portion; and a
flexible distal portion with an irrigation tip, the middle portion
further having an actuator. In one embodiment, the proximal portion
has is a rigid proximal portion and further includes an irrigation
connector. In a further embodiment the actuator has a distal
actuator flange and a proximal actuator flange. In another
embodiment, the irrigation tip has a tip opening and one or more
radially facing openings. In another embodiment the rigid middle
portion of the irrigation catheter may contain a stiffening member
that surrounds the irrigation lumen. In addition, the catheter
proximal portion may contain a stiffening member that surrounds the
irrigation lumen.
[0025] In another aspect, the invention is a method for treating a
target space in the nasal anatomy. The method involves positioning
an irrigation catheter having an irrigation lumen and further
having a proximal portion, a rigid middle portion and a flexible
distal portion in the nasal anatomy. The flexible distal portion
has an irrigation tip and the middle portion has an actuator. The
method further involves connecting a fluid source to the irrigation
catheter and delivering fluid to the target space from the fluid
source though the irrigation catheter. In another embodiment the
method includes the delivering the fluid at a flow rate of between
50 ml/min and 200 ml/min. In a further embodiment of the method,
the target space is selected from the group consisting of the
frontal sinus, the maxillary sinus, the ethmoid sinus, and the
sphenoid sinus opening.
[0026] In yet another embodiment of the method, the fluid is
selected from the group consisting of water, saline, contrast
agents, antimicrobial agents anti-inflammatory agents,
decongestants , mucous thinning agents, anesthetic agents,
analgesic agents, anti-allergenic agents, allergens,
anti-proliferative agents, hemostatic agents, cytotoxic agents, and
biological agents or combinations of any of the above.
[0027] In a further aspect, the invention is a method for treating
a target space in the nasal anatomy. The method involves
positioning an irrigation catheter having an irrigation lumen and
further having a proximal portion, a rigid middle portion and a
flexible distal portion in the nasal anatomy. The flexible distal
portion has an irrigation tip and the middle portion has an
actuator. The method further involves connecting a vacuum source to
the irrigation catheter and suctioning the target space though the
irrigation lumen. In another embodiment of the method, the target
space is selected from the group consisting of the frontal sinus,
the maxillary sinus, the ethmoid sinus, and the sphenoid sinus
opening.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 is a simplified side view of a medical device
according to an embodiment of the present invention;
[0029] FIG. 2 is an enlarged view of the distal end of the medical
device shown in
[0030] FIG. 1.
[0031] FIG. 3 is an enlarged view of the actuator of the medical
device shown in FIG. 1.
[0032] FIG. 4 is an enlarged view of the distal end of the medical
device shown in FIG. 1.
[0033] FIG. 5 is an illustration of a partial sagital sectional
view through a human head showing the use of an irrigation catheter
as described herein to perform at least one of irrigation, suction,
and delivery of a therapeutic or diagnostic substance or retrieval
of a culture.
[0034] FIG. 6 is a side view of a medical device for the treatment
of a sinus opening according to an embodiment of the present
invention.
[0035] FIG. 7 is a simplified side of a medical device according to
an alternative embodiment of the present invention.
DETAILED DESCRIPTION
[0036] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are identically numbered. The drawings, which are not
necessarily to scale, depict exemplary embodiments for the purpose
of explanation only and are not intended to limit the scope of the
invention. The detailed description illustrates by way of example,
not by way of limitation, the principles of the invention. This
description will clearly enable one skilled in the art to make and
use the invention, and describes several embodiments, adaptations,
variations, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0037] As used herein, the terms "about" or "approximately" for any
numerical values or ranges indicate a suitable dimensional
tolerance that allows the part or collection of components to
function for its intended purpose as described herein.
[0038] Medical devices according to embodiments of the present
invention are beneficial in that, for example, their configuration
provides for a particularly efficient preparation and treatment of
a patient's sinus and is mechanically simple. Moreover, the
simplicity of the medical devices provides for them to be
manufactured in a cost effective manner. In addition, the medical
device according to embodiments of the present invention is
sufficiently stiff that it can be beneficially employed to access
sinus anatomy followed by a convenient suction and/or irrigation of
the sinus.
[0039] FIG. 1 is a simplified side view of an irrigation catheter
100 for the treatment of a sinus (for example a frontal sinus,
maxillary sinus, ethmoid sinus, or sphenoid sinus) according to an
embodiment of the present invention. The sinus irrigation catheter
100 has a flexible distal portion 102 and a rigid middle portion
104 and a proximal portion 106 with a stiffness that is
intermediate the flexible distal portion 102 and the rigid middle
portion 104.
[0040] The flexible distal portion 102 of the sinus irrigation
catheter 100 will now be described in greater detail. Referring now
to FIG. 2, and enlarged view of the irrigation tip 110 can be seen
with both a forward facing tip opening 112 and radially facing
openings 114 to provide a means to irrigate from within a target
sinus for diagnostic or therapeutic purposes. By radially facing
openings, is intended that the flow through the openings may be at
90 degrees from the flow through the tip opening, but it may also
be at other angles such as 30, 45 or 60 degrees or other angles
between 0 and 90 degrees. The irrigation catheter 100 is designed
to irrigate the sinus through the tip opening 112 and the three
radially facing openings 114 in the irrigation tip 110. Further,
instead of delivering fluid, a vacuum may be applied and a culture
may be obtained by suctioning through with the tip opening 112 or
the radially facing openings 114.
[0041] As shown in FIG. 1 in some embodiments, direct visualization
markers and/or radiographic markers may be disposed along the
flexible distal portion 102. Generally, "direct visualization
markers" refers to markers that may be viewed during use with the
naked eye or by use of an endoscope, while radiographic markers
include radiopaque material and are viewed using a radiographic
device such as intra-operative fluoroscopy. In one embodiment, a
first distal direct visualization marker 120, which has a distal
edge aligned with the distal end of the irrigation tip 110 and is
colored white for easy visualization and a radiographic marker 130
is disposed over the first distal direct visualization marker 120,
the radiographic marker 130 including a radiopaque material that
can be viewed using a radiographic device such as intraoperative
fluoroscopy.
[0042] Direct visualization markers can be positioned in a number
of locations along the flexible distal portion 102 of the sinus
irrigation catheter 100. Although one embodiment is described here
with reference to FIG. 1, other variations may be substituted in
alternative embodiments. In one embodiment, flexible distal portion
102 may have a dark color, such as black, dark blue, dark grey or
the like or may be transparent, and markers may have a light color,
such as white, green, red or the like. In some embodiments, markers
may have different colors and/or different widths to facilitate
distinguishing the markers from one another during use. This
contrast in colors may facilitate viewing the markers in a darkened
operation room and/or when using an endoscope inside a patient in
the presence of blood.
[0043] A second direct visualization marker 122 is disposed on the
flexible distal portion 102 such that the middle of the marker is 3
cm apart from the proximal end of the first direct visualization
marker 120. Visualization of this marker 122 indicates to the user
that 3 cm of the flexible distal portion 102 has exited into the
target anatomy. In one embodiment, the second distal direct
visualization marker 122 may be about 2 mm wide and green in color,
while the first marker 120 is about 2 mm and white in color. Of
course, any of a number of different size and color combinations
may be used alternatively.
[0044] A third direct visualization marker 124 is disposed on the
flexible distal portion 102 such that the middle of the marker is 1
cm apart from the middle of the second direct visualization marker
122. Visualization of this marker 124 indicates to the user that a
further 1 cm of the flexible distal portion 102, or a total of 4 cm
of the flexible distal portion 102, has exited into the target
anatomy. In one embodiment, the third direct visualization marker
may be about 2 mm wide and white in color, while the second marker
122 is about 2 mm and green in color. Of course, any of a number of
different size and color combinations may be used
alternatively.
[0045] A fourth direct visualization marker 126 is disposed on the
flexible distal portion 102 such that the middle of the marker is 1
cm apart from the middle of the third direct visualization marker
124. Visualization of this marker 126 indicates to the user that a
further 1 cm of the flexible distal portion 102, or a total of 5 cm
of the flexible distal portion 102, has exited into the target
anatomy. As shown in FIG. 1, the fourth distal shaft marker is a
double marker to distinguish the third and fourth distal shaft
markers 124 and 126 one from one another. In one embodiment, the
two markers forming the fourth distal shaft marker 126 are each
0.75 mm wide and white in color, however, the size and color of the
marker can be changed in alternative embodiments. The differences
in the direct visualization markers' color, length and number of
marks give the indication of the relative location proximal to the
sinus under endoscopic visibility. Using an endoscope, the
physician user can identify the length of catheter that has been
advanced and retracted and/or can approximate a location of the
catheter 100 relative to patient anatomy such as a paranasal sinus
ostium, other paranasal sinus opening, or other openings in the
ear, nose or throat. Of course, in alternative embodiments, distal
shaft markers having different numbers, sizes, colors and positions
along the catheter shaft may be used. Referring again to FIG. 1,
the irrigation tip 110 is made of a white extrusion that is fused
to the inside of the flexible distal portion 102. Although the
illustrative example shows this irrigation tip 110 to be a white
extrusion, any color may be useful to distinguish the tip 110 from
the remainder of the flexible distal portion 102. The flexible
distal portion 102 defines the irrigation lumen 140 and is made of
a flexible, biocompatible polymer material, such as nylon,
polyethylene, polyether ether ketone (PEEK), or polyether block
amides (e.g. Pebax for example). In the embodiment shown in FIG. 1,
the material is Pebax. The material is preferably clear such that
the physician user can see materials being delivered to a target
location of a sinus anatomy, as well as being removed from the
anatomy. The clear material also allows for visual trouble-shooting
of the device, e.g. should the catheter 100 become clogged the user
can visualize where the clog has occurred.
[0046] The rigid middle portion 104 of the catheter 100 includes a
stiffening member 142, and in a particular embodiment this member
is a 304 stainless steel hypotube shaft that surrounds the Pebax
irrigation lumen 140. The proximal portion 106 of the catheter 100
is a combination of materials, a nylon sleeve 146 disposed about
the pebax irrigation lumen 140. The three sections of disparate
stiffness (the Pebax flexible distal portion 102, the hypotube and
Pebax rigid middle section 104 and the nylon and Pebax proximal
portion of intermediate stiffness 106) provide for ease of
insertion of the irrigation catheter into and navigation through
the tortuous sinus anatomy. Further, the physician user may be able
to hold or support the catheter 100 by grasping just one location
on the rigid middle section 104. Additionally, the middle portion
104 and the proximal portion 106 will maintain axial alignment when
not being otherwise stressed (as, for example, when being inserted
into the single-handed device described below with regard to FIG.
6).
[0047] The rigid middle portion 104 has a proximal end 145 and a
distal end 147. At its proximal end 145, as shown in FIG. 3, the
rigid middle portion 104 further includes an actuator 150. The
actuator 150 contains treads 152, 154, 156, and 158 to provide a
grip feature when the irrigation catheter is used as an individual
unit, and as sliding surfaces which engaged in a handle (as
described further below). These treads are shown on one side of the
actuator 150, but are duplicated on the other side of the actuator
150. In the embodiment shown in FIG. 3, there are 4 treads on each
side of the actuator 150, but there can be 2, 3, 4, 5, 6 or more
treads as well. In FIG. 3, the first tread 152 and the last tread
158 may contact a handle for minimization of sliding friction and
maximization of the direction between contacting surfaces for
maximum stability within the handle. The distal actuator flange 164
and the proximal actuator flange 166 are shown with ridges on
either side of the flanges. Insertion of the guide catheter 100
into the nasal anatomy can be effected by a thumb or single finger
of the physician user as pressure is applied on the flange, pulling
it toward the nasal anatomy. Similarly, removal from the nasal
anatomy can be effected by the thumb or single finger of the
physician user as pressure is applied on the flange, pushing it
away from the nasal anatomy. Such telescoping operation enables
single handed insertion of the catheter 100 and irrigation of the
sinuses.
[0048] A luer connector 160 connects the proximal end of the
proximal portion 106 of irrigation catheter 100 to a source of
irrigation or suction. In the embodiment shown in FIG. 4, a 45
degree slanted positioner 162 allows for ease of use with the
single handled sinus treatment device described below with regard
to FIG. 6. A syringe (e.g., having a volume of about 10 cc to about
60 cc, for example) may be connected to luer connector 160 The
syringe may be used to drive the irrigation fluid out of the
openings 112 and 114 by hand pressure by the operator on a hand
pushable plunger of the syringe. Fluid pressures of about 4 to
about 6 pounds per square inch (psi) are typically generated when
using a 60 cc syringe, and pressures of about 15 to about 25 psi
can be generated using a 10 cc syringe. Alternatively, the luer
connector 160 may be connected to a high pressure valve which is in
turn connected to a high pressure inflation device. The high
pressure inflation device, that may be a screw-threaded pump of a
type that can be used to inflate balloon catheters, has a
screw-threaded plunger that can be torqued (or, alternatively, a
rack and pinion driving mechanism can be substituted) to develop
high pressure within a reservoir that contains an irrigation fluid
(e.g., saline or other irrigating fluid used in ear, nose and
throat practice), and locked via a locking mechanism to maintain
the high pressure until it is released by opening the valve. Other
types of high pressure pumps could be substituted, including
motor-driven pumps.
[0049] Instead of or addition to use of the catheter 100 for
irrigation the sinuses, as noted earlier, the catheter may be used
to suction materials from within the sinuses. For use solely to
suction the sinuses, a suction source such as a vacuum pump or
other suction system may be connected to the luer connector 160.
For use of the catheter for both irrigating and suctioning the
sinuses, a dual-use connector such as a valve or Y-connector may be
connected to the luer connector 160 to enable switching between the
irrigation source and the suction source.
[0050] In one embodiment, the valve that is connected to the luer
connector 160 and to a high pressure inflation device may be a high
pressure push-button valve that is normally closed, but opens upon
depressing a push-button. Of course, other alternative types of
valves can be substituted as long as they are rated for
sufficiently high pressure and are operable between closed and open
states. Once the irrigation catheter 100 has been appropriately
placed in a target where it is desired to perform the high pressure
irrigation, pressure is built up in the reservoir by advancing a
plunger, while the valve remains closed. Once sufficient pressure
has been established (e.g., pressures of about 50 to 100 psi, or
about 100 to 150 psi, or about 150 to 300 psi, or pressures greater
than about 25 psi can be generated), the valve is opened, and a
high pressure spray is impulsively driven and jets out of openings
112 and 114, developing vortices of flow in directions
circumferentially around irrigation tip 110 to provide a scrubbing
type of wash to the walls of the sinus cavity to remove debris,
mucus, fungus, etc. The irrigation flow rate is approximately 100
ml/min and may be between about 50 and 200 ml/min or between about
75 and 125 ml/min with a maximum flow rate of 250 ml/min.
[0051] Irrigation catheter 100 is configured to irrigate and
suction fluids deep within the sinuses, as well as other areas
within the paranasal space. Irrigation catheter 100 is sized
appropriately to be delivered into adult as well as pediatric
sinuses, including maxillary, sphenoid, ethmoid and frontal
sinuses. Irrigation catheter 100 can also be used to deliver
diagnostic or therapeutic substances into the sinuses or other
areas in the paranasal space. Examples of such diagnostic or
therapeutic substances include, but are not limited to: contrast
agents, pharmaceutically acceptable salt or dosage form of an
antimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic,
antifungal, etc.), a corticosteroid or other anti-inflammatory
(e.g., an NSAID), a decongestant (e.g., vasoconstrictor), a mucous
thinning agent (e.g., an expectorant or mucolytic), an anesthetic
agent with or without vasoconstrictor (e.g., Xylocaine with or
without epinephrine, Tetracaine with or without epinephrine), an
analgesic agent, an agent (anti-allergenic agent) that prevents of
modifies an allergic response (e.g., an antihistamine, cytokine
inhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator),
an allergen or another substance that causes secretion of mucous by
tissues, anti-proliferative agents, hemostatic agents to stop
bleeding, cytotoxic agents e.g. alcohol, and biological agents such
as protein molecules, stem cells, genes or gene therapy
preparations.
[0052] Referring now to FIG. 1, in one embodiment, the irrigation
catheter may include a forward facing tip opening 112 and three
radially facing openings 114 on irrigation tip 110 spaced 120
degrees apart, with the inner diameter of the forward facing tip
opening being 0.037 inches and each of the side openings having a
inner diameter of 0.026 inches. In the illustrative embodiment, the
inner diameter of the distal portion 102 of the irrigation tip 110
at the position of the side openings that is proximal to the distal
visualization marker 120 is about 0.042 inches. Alternative
embodiments may include any suitable alternative number of side
openings distributed in any suitable pattern such as a helical
pattern. In one embodiment, a first side opening may be placed at
about 5 mm..+-..0.5 mm from the distal end 108 of medical device
100, a second side opening may be placed at about 6 mm..+-..0.5 mm
from the distal end 108 of medical device 100, and a third side
opening may be placed at about 7 mm..+-..0.5 mm from the distal end
108 of medical device 100, with each of these measurements being
from the distal end to approximately the center of each side
opening. Each side opening may have any suitable diameter in
various alternative embodiments. For example, in one embodiment,
each side opening may have a diameter of between about 0.020 inches
and about 0.050 inches or between about 0.030 inches and about
0.040 inches and or about 0.033 inches. In an alternative
embodiment, the medical device 100 may contain an integrated
guidewire such that there is no irrigation from the distal end of
the device, but only from the radially facing openings.
[0053] FIG. 5 is an illustration of partial sagital sectional view
through a human head showing access to a paranasal sinus by an
irrigation system as described herein to perform at least one of
irrigation, suction, or delivery of a therapeutic or diagnostic
substance or retrieval of a culture. In FIG. 5, the sinus
irrigation catheter 100 is introduced through a nostril and through
a nasal cavity 500 to a location close inside of a sphenoid sinus
502. For other harder to reach anatomical locations, such as the
maxillary sinus, for example, a sinus guide may be used. For
accessing a maxillary sinus, a sinus guide having a bend of 110
degrees may be needed. Sinus guides may be straight, malleable, or
may incorporate one or more preformed curves or bends as further
described in U.S. Patent Publication Nos. 2006/004323;
2006/0063973; and 2006/0095066, for example, each of which are
incorporated herein by reference in their entireties.
[0054] The distal end of irrigation catheter is inserted deep into
sinus 502 so that tip opening 112 and radially facing openings 114
are positioned into any portion of the sinus anatomy, but in many
cases may be positioned well within the sinus cavity to perform at
least one of the functions noted above. Further, two functions,
such as irrigation and suction may be performed with the irrigation
system described herein. FIG. 5 illustrates an irrigation procedure
being performed, as irrigation fluid 510 is jetted through the
openings 112 and 114 to establish vortices to clean the walls of
the sinus by the irrigation flow.
[0055] It is further noted that irrigation systems described herein
are not limited to only being delivered through a natural anatomic
pathway, but can also be delivered though a surgical opening to
irrigate, suction, deliver therapeutic and/or diagnostic substances
and/or take cultures. For example, a hole may be trephined to
provide direct access to the frontal sinus and an irrigation system
as described herein can be delivered through the hole to flush a
frontal sinus. This technique can be particularly useful for a
sinus that does not communicate normally with the middle meatus. As
another example, the anterior wall of the ethmoid bulla can be
punctured and an irrigation system as described herein can be
inserted therethrough to flush the anterior ethmoid sinuses. This
procedure may be done after removal of an ethmoid sinus stent, for
example. An irrigation system described herein can be delivered
through a maxillary antrostomy or Caldwell-Luc incision to perform
any of the above described functions. Still further, an irrigation
system as described herein may be delivered through the Eustachian
tube or an incision to access the middle ear to perform any of the
above-described functions in the location of the middle ear.
[0056] Delivery of an irrigation system, with or without use of a
guide catheter may be additionally or alternatively visualized by
using an endoscope or by using fluoroscopy, electromagnetic or
optical guidance, including 3-dimensional visualization such as CT
or MRI visualization or other known visualization techniques.
[0057] In many of the embodiments described above, an irrigation
catheter 100 may be delivered into a sinus with or without a
guidewire. The catheter 100 may be delivered over a guidewire, or
the guidewire may be incorporated into the irrigation catheter 100.
To deliver an irrigation catheter over a guidewire, for example, a
distal end of the guidewire may first be advanced into a sinus
through a guide catheter, as described above and in a number of the
patent applications previously incorporated by reference. Systems
including guide catheters (Relieva or Relieva Flex Sinus Guide
Catheters), guidewires (Relieva Sinus Guidewire or Relieva Luma or
Luma Sentry Guidewires) and handles (Relieva Sidekick Sinus Guide
Catheter Handle) may be purchased from Acclarent Inc, Menlo Park,
Calif. In one embodiment, the proximal end of a Relieva Sinus Guide
Catheter is inserted into the fitting of a Relieva Sidekick Sinus
Guide Catheter Handle. The guide catheter has an inner diameter
that is greater than the outer diameter of the irrigation catheter.
The guide catheter is placed near the target anatomy, a guidewire
is advanced through the guide catheter and the irrigation catheter
100 may be advanced through the guide catheter and over the wire
into the target anatomy. The irrigation catheter may be introduced
absent the guidewire or the guidewire may be inserted into the
irrigation catheter and the guidewire and irrigation catheter may
be inserted into the guide catheter and positioned at the target
anatomy.
[0058] Placement of a guidewire in a desired position in a sinus
may be confirmed by fluoroscopy. Once the guidewire is in position,
the irrigation catheter 100 may be advanced over the guidewire to
position a distal portion of the catheter in the sinus. In various
embodiments, the irrigation catheter may be advanced over the
guidewire through a guide catheter or, alternatively, over the
guidewire without using a guide catheter. Positioning of a distal
portion of the irrigation catheter in the desired sinus may be
confirmed using fluoroscopy, in embodiments where the irrigation
catheter distal portion includes a radiopaque marker or material.
In some embodiments, the guidewire may then be withdrawn through
the irrigation catheter. Irrigation fluid may then be introduced
through the irrigation catheter, and in some embodiments fluid may
be suctioned back through the irrigation catheter. In various
embodiments, any other suitable guidewire-based delivery techniques
may be employed to advance an irrigation catheter of the present
invention.
[0059] These procedures may be performed as stand-alone procedures,
or they may be follow-up procedures performed after performing some
other procedure such as a dilation of the ostium. A medical device
600 for treating a sinus opening is shown in FIG. 6. This device
600 is further described in U.S. Publication No. 2012/0071856 and
incorporated herein by reference in its entirety. The medical
device 600 for the treatment of a sinus opening includes a guide
catheter 602, a guide wire 604, a balloon catheter 606, a guide
wire movement mechanism 608, a balloon catheter movement mechanism
610, and a suction pathway 612. The handle 614 is ergonomically
designed such that the finger anchoring pegs 616a, 616b and 616c
can be placed between the fingers of either a right handed or left
handed user to provide for support of the device 600. The locking
tab 618 prevents the balloon catheter mechanism 610 from moving
proximally when it is in the up position, but allows for movement
distally. When the locking tab 618 is in the down position, the
balloon catheter 606 and guide wire 604 can be removed such that an
irrigation catheter 100 can be inserted into the handle 614 and
through the guide catheter 602. The 45 degree slanted positioner
162 on the semi-flexible tubing 106 allows the proximal portion 106
to slide above the proximal end of the handle 614 without
interference so that the luer 160 can be positioned above the
handle 614 and connected to a vacuum or fluid source. The distal
end of the sinus irrigation catheter 100 is positioned at the
dilated sinus ostium for irrigation, suction, or delivery of a
therapeutic or diagnostic substance or retrieval of a culture.
Other embodiments of the proximal portion 106 that would allow for
positioning of the luer 160 above the handle 614 would include a
permanently deformable proximal portion 106 or a hook or other
attachment mechanism that could be connected to the proximal
portion 106 to position the proximal portion 106 above the handle
614. Such an embodiment is shown in FIG. 7. In this embodiment, the
distal portion 702 of the sinus irrigation catheter 700 is flexible
as described earlier to provide for ease of insertion and
navigation through the tortuous sinus anatomy. The middle portion
704 of the sinus irrigation catheter 700, also as described earlier
is rigid such that it easily be held and supported and can be
telescoped into a guide catheter (not shown) in a single handed
operation by pushing or pulling actuator 710 distally toward the
guide catheter. In this embodiment, the proximal portion 706 has a
rigidity similar to the middle portion 704 such that the proximal
portion 706 forms a hook (in this case, a curved hypotube) that
positions the irrigation connector, luer 708, above the remainder
of the catheter 700. In this way, the luer 708 is positioned above
the device handle 614 shown in FIG. 6 and single handed operation
of the catheter 700 is enabled without interference by the
irrigation or suction system.
[0060] The invention has been described with reference to certain
examples or embodiments of the invention, but various additions,
deletions, alterations and modifications may be made to those
examples and embodiments without departing from the intended spirit
and scope of the invention. For example, any element or attribute
of one embodiment or example may be incorporated into or used with
another embodiment or example, unless otherwise specified or if to
do so would render the embodiment or example unsuitable for its
intended use. Also, where the steps of a method or process have
been described or listed in a particular order, the order of such
steps may be changed unless otherwise specified or unless doing so
would render the method or process unworkable for its intended
purpose. All reasonable additions, deletions, modifications and
alterations are to be considered equivalents of the described
examples and embodiments and are to be included within the scope of
the following claims.
* * * * *